Home telemonitoring for type 2 diabetes: an evidence-based analysis.

UNLABELLED: In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry's newly released Diabetes Strategy.After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site, https://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,DIABETES STRATEGY EVIDENCE PLATFORM: Summary of Evidence-Based AnalysesContinuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based AnalysisBehavioural Interventions for Type 2 Diabetes: An Evidence-Based AnalysisBARIATRIC SURGERY FOR PEOPLE WITH DIABETES AND MORBID OBESITY: An Evidence-Based SummaryCommunity-Based Care for the Management of Type 2 Diabetes: An Evidence-Based AnalysisHome Telemonitoring for Type 2 Diabetes: An Evidence-Based AnalysisApplication of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario

OBJECTIVE: The objective of this report is to determine whether home telemonitoring and management of blood glucose is effective for improving glycemic control in adults with type 2 diabetes.

BACKGROUND: An aging population coupled with a shortage of nurses and physicians in Ontario is increasing the demand for home care services for chronic diseases, including diabetes. In recent years, there has also been a concurrent rise in the number of blood glucose home telemonitoring technologies available for diabetes management. The Canadian Diabetes Association (CDA) currently recommends self-monitoring of blood glucose for patients with type 2 diabetes, particularly for individuals using insulin. With the emergence of home telemonitoring, there is potential for improving the impact of self-monitoring by linking patients with health care professionals who can monitor blood glucose values and then provide guided recommendations remotely. The MAS has, therefore, conducted a review of the available evidence on blood glucose home telemonitoring and management technologies for type 2 diabetes. EVIDENCE-BASED ANALYSIS OF EFFECTIVENESS:

RESEARCH QUESTION: Is home telemonitoring of blood glucose for adults with type 2 diabetes more efficacious in improving glycemic control (i.e. can it reduce HbA1c levels) in comparison to usual care?

LITERATURE SEARCH: Must involve the frequent transmission of remotely-collected blood glucose measurements by patients to health care professionals for routine monitoring through the use of home telemonitoring technology.

INTERVENTION: Monitoring must be combined with a coordinated management and feedback system based on transmitted data.

CONTROL: Usual diabetes care as provided by the usual care provider (usual care largely varies by jurisdiction and study).

POPULATION: Adults ≥18 years of age with type 2 diabetes.

FOLLOW-UP: ≥6 months.

SAMPLE SIZE: ≥30 patients total.PUBLICATION TYPE: Randomized controlled trials (RCTs), systematic reviews, and/or meta-analyses.PUBLICATION DATE RANGE: January 1, 1998 to January 31, 2009.

EXCLUSION CRITERIA: Studies with a control group other than usual care.Studies published in a language other than English.Studies in which there is indication that the monitoring of patients' diabetic measurements by a health care professional(s) was not occurring more frequently in intervention patients than in control patients receiving usual care.

OUTCOMES OF INTEREST: The primary outcome of interest was a reduction in glycosylated hemoglobin (HbA1c) levels.

SEARCH STRATEGY: A comprehensive literature search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, The Cochrane Library, and INAHTA for studies published between January 1, 2007 and January 31, 2009. The search was designed as a continuation of a search undertaken for a systematic review by the Canadian Agency for Drugs and Technologies in Health, originally encompassing studies published from 1950 up until July of 2008 and which reviewed home telemonitoring in comparison to usual care for the management of type 1 and type 2 diabetes.

SUMMARY OF FINDINGS: A total of eight studies identified by the literature search were eligible for inclusion (one was excluded post-hoc from analysis). Studies varied considerably on characteristics of design, population, and intervention/control. Of note, few trials limited populations to type 2 diabetics only, thus trials with mixed populations (type 1 and type 2) were included, though in such cases, the majority of patients (>60%) had type 2 diabetes. No studies restricted inclusion or analyses by diabetes treatment type (i.e. populations were mixed with respect to those on insulin therapy vs. not) and studies further varied on whether intervention was provided in addition to usual care or as a replacement. Lastly, trials often included blood glucose home telemonitoring as an adjunct to other telemedicine components and thus the incremental value of adding home telemonitoring remains unclear. The overall grading of the quality of evidence was low, indicating that there is uncertainty in the findings. Meta-analysis of the seven trials identified a moderate but significant reduction in HbA1c levels (~0.5% reduction) in favour blood glucose home telemonitoring compared to usual care for adults with type 2 diabetes). Subgroup analyses suggested differences in effect size depending on the type of intervention, however, these findings should be held under caution as the analyses were exploratory in nature and intervention components overlapped between subgroups. Executive Summary Table 1:Meta-Analyses of Reduction in HbA(1c) Values for Analyzed StudiesGroupEstimate of effect(95% Confidence Interval)Statistical Heterogeneity (I(2))FOLLOW-UP values     All studies-0.48 [-0.70 to -0.26]45%     Upload studies-0.39 [-0.66 to -0.13]48%     Web entry studies-0.66 [-0.99 to -0.33]0%Change-from-baseline values (p=0.5)     All studies-0.50 [-0.80 to -0.19]65%     Upload studies-0.26 [-0.55 to 0.02]45%     Web entry studies-0.78 [-1.14 to -0.43]0%Change-from-baseline values (p=0.65)     All studies-0.52 [-0.82 to -0.21]73%     Upload studies-0.25 [-0.51 to 0.01]46%     Web entry studies-0.78 [-1.08 to -0.48]0%Change-from-baseline values (p=0.85)     All studies-0.54 [-0.84 to -0.24]85%     Upload studies-0.21 [-0.41 to 0.00]47%     Web entry studies-0.81 [-1.11 to -0.51]49%

CONCLUSIONS: Based on low quality evidence, blood glucose home telemonitoring technologies confer a statistically significant reduction in HbA1c of ~0.50% in comparison to usual care when used adjunctively to a broader telemedicine initiative for adults with type 2 diabetes.Exploratory analysis suggests differences in effect sizes for the primary outcome when analyzing by subgroup; however, this should only be viewed as exploratory or hypothesis-generating only.Significant limitations and/or sources of clinical heterogeneity are present in the available literature, generating great uncertainty in conclusions.More robust trials in type 2 diabetics only, utilizing more modern technologies, preferably performed in an Ontario or a similar setting (given the infrastructure demands and that the standard comparator is usual care), while separating out the effects of other telemedicine intervention components, are needed to clarify the effect of emerging remote blood glucose monitoring technologies.